K230286 is an FDA 510(k) clearance for the Assert-IQ™ Insertable Cardiac Monitor. This device is classified as a Recorder, Event, Implantable Cardiac, (without Arrhythmia Detection) (Class II - Special Controls, product code MXC).
Submitted by Abbott Medical (Sylmar, US). The FDA issued a Cleared decision on May 17, 2023, 104 days after receiving the submission on February 2, 2023.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.2800.
| 510(k) Number | K230286 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 02, 2023 |
| Decision Date | May 17, 2023 |
| Days to Decision | 104 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
| Product Code | MXC — Recorder, Event, Implantable Cardiac, (without Arrhythmia Detection) |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.2800 |